Senior Engineer, Device and Packaging Development

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Senior Engineer, Device and Packaging Development Job Type: Full-Time Location: New Brunswick, NJ Drug Product Development (DPD) Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration, and cutting-edge innovation to achieve this commitment. BMS’s internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities. We collaborate closely with our colleagues in R&D and Commercial to design our drug products. Here, you’ll get the chance to grow and thrive through opportunities that are uncommon in scale and scope. Position Summary: The Sterile Product and Device Development team within the Drug Product Development team and greater Product Development and Supply organization supports the BMS pipeline to create patient centric products. We now have a vacancy for a Senior Engineer, Device and Packaging Development to join our team and contribute to our success in meeting the needs of our business and our patients. The right candidate will bring the necessary skills, expertise, leadership, and passion for continuous improvement to an already dynamic team. Delivering on time, driving innovation, and fostering collaboration with stakeholders are key to this role. The Senior Engineer, Device and Packaging Development is an individual contributor responsible for the following: Support design, development, evaluation and lifecycle management of drug-device combination products (e.g., autoinjectors, prefilled syringes, wearable injectors, nasal delivery devices). Lead and execute technical tasks and projects with limited supervision, contributing to cross-functional teams to ensure combination products meet safety, efficacy, and usability requirements across the development lifecycle. Develop and maintain design history files (DHFs), design inputs/outputs, verification & validation (V&V) documentation, and risk management records. Evaluate and develop novel device and packaging solutions, focused on sterile and oral dosage forms, based on patient, user, and technical requirements. Manage device and packaging development activities from concept through launch while maintaining project objectives, timelines, and costs. Provide technical expertise in the development of device and primary packaging component specifications, and support manufacturing teams assisting in resolving problems associated with device and packaging components. Facilitate continuous improvement initiatives to increase productivity of team and establish group synergies with stakeholder organizations. Maintain familiarity with evolving regulatory and compendia changes and translate device and packaging industry trends into business opportunities. Provide technical assistance on sterile packaging and device constituent parts for quality and regulatory activities, including preparation of technical documents for regulatory filings. Partner with key stakeholders to ensure system-level requirements for drug device combination products are developed, verified, and validated in accordance with design controls. Qualifications: Minimum 4 years of relevant experience in the pharmaceutical, biotechnology, or medical device industry; experience in healthcare, food, or cosmetic industries is also relevant. Minimum of a Master’s degree in Mechanical, Biomedical, or Industrial Engineering, or a relevant science and engineering discipline; PhD preferred. Working knowledge of design controls, V&V execution and FMEA. Working knowledge of FDA 21 CFR Parts 4 & 820; ISO 13485, 14971, 11608 standards. Solid background in materials, such as glass, plastics used for containers, rubber closures, seals, syringes. Experience in writing, executing, reporting, and presenting device and packaging system evaluations. Strong understanding of global regulations regarding device and packaging. Able to manage multiple tasks with minimal supervision and independently prioritize activities based on timelines. Ability to travel domestically and internationally, up to 15%. Ability to apply Lean and Six Sigma methodologies to process and product improvement is a plus. Demonstrated ability to: Influence areas not under direct control to achieve objectives. Work in a matrix environment and effectively support internal & external manufacturers and suppliers. Apply design controls, V&V, and risk-management principles across the combination product lifecycle. Apply strong technical, analytical and problem-solving skills, as well as strong mechanical aptitude. Apply strong technical writing skills to draft protocols, reports, test methods, procedures, work instructions. Communicate effectively, including internal/external presentations to suppliers, sites, and Sr. Management. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: New Brunswick - NJ - US: $109,570 - $132,767 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. ​Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medi